Day One

Introductions

Format of ISO 13485:2003 standards

• Structure of the standard

• Contents and purpose of each section

• Correspondence to and differences between ISO 9001:2000

Introduction section

• Process approach - exercise

Overview section

• Scope

• Application

• Exclusions – exercise

• Normative references

• Terms and definitions

Requirements

4 – Quality management system

– Process interaction - exercise

Lunch

Requirements

5 – Management responsibility

– Communication process - exercise

6 – Resource management

– Infrastructure – exercise

7 – Product realization

Day one summary and questions

Day Two

Extensive group assignments with focus on the new processes

7 – Product realization (continued)

8 – Measurement, Analysis and improvement

– Audit checklists — exercise

– Process audit — exercise

Lunch

8 – Measurement, Analysis and improvement (continued)

– Analysis of data exercise

Development of the strategy for transition to the new requirements

– Identification of applicable standards and regulations

– Identification of the new processes
–Transition strategy – group assignment and exercise

ISO Training Course summary and questions